Senior Engineering Lead, Biologics External Manufacturing

HireLifeScience

South San Francisco (CA)

Remote

USD 142,000 - 224,000

Full time

3 days ago

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Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

HireLifeScience seeks an Associate Director of Engineering in Biologics External Manufacturing Technology to lead technical transfers with external partners and ensure successful commercial supply. The role requires extensive biologics manufacturing experience, strategic leadership, and collaboration across multiple technical functions to minimize risk and optimize performance.

The position is based in the United States with flexible work arrangements and reports to the Director of Biologics

Qualifications

Bachelor's degree in Engineering or applicable Science required; advanced degree preferred.
Minimum of 8 years post-bachelor's degree experience in Drug Substance/Drug Product biologics manufacturing or related engineering support.

Responsibilities

Provide a single technical contact to External Partners and oversee tech transfer delivery.
Lead cross-functional teams to support manufacturing operations and partner interactions.
Develop validation strategies for new and existing products in collaboration with partners.
Assess viability of partner processes and ensure adherence to standards and deliverables.
Coordinate with Procurement, External Manufacturing, QA, and Regulatory for partner evaluations.
Ensure readiness for inspections and transfer readiness for new product introductions.